Peri-implantitisPerio-implantsNCT02241577
Surgical and Non-surgical Treatment of Peri-implantitis
A study testing Surgical treatment and Non-surgical treatment in people with Peri-implantitis, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Surgical treatment and Non-surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals with at least one dental implant with peri-implantitits
- Individuals with good general health conditions;
- Individuals presenting at least 10 natural teeth;
- Individuals with no signs of active periodontitis
Who cannot join
- Individuals who received periodontal treatment in the last three months
- Pregnant
- Systemic condition that interferes with treatment such as diabetes
- Individuals who are taking or have taken antibiotics or anti-inflammatory medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up
This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics.
- Conditions
- Peri-implantitis
- Being tested
- Surgical treatment, Non-surgical treatment
- Keywords
- peri-implantitis, dental implants, randomized controlled trial, non-surgical periodontal treatment, will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentProcedure or surgery
Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia
Non-surgical treatmentProcedure or surgery
Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Experimental | Surgical access for scaling and disinfection of dental implant Receives: Procedure: Surgical treatment |
| Non-surgical treatment | Experimental | Non-surgical subgingival scaling and disinfection of dental implant Receives: Procedure: Non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth reduction
Measured: 12 months
Secondary outcomes (6)
Clinical attachment level changes
Measured: 12 months
Alveolar bone level changes
Measured: 12 months
Subgingival microbiota changes
Measured: 12 months
Gingival crevicular fluid immune-inflammatory biomarkers
Measured: 12 motnhs
Serum biomarkers of inflammation
Measured: 12 months
Bleeding on probing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Nogueira Haas, Federal University of Rio Grande do Sul
- Investigators
- Cassiano K Rosing, PhD, Study chair, Federal University of Rio Grande do SulJoao Augusto P Oliveira, MS, Principal investigator, Federal University of Rio Grande do SulTassiane P Wagner, DDS, Principal investigator, Federal University of Rio Grande do SulFernando S Rios, MS, Principal investigator, Federal University of Rio Grande do SulRicardo SA Costa, MS, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241577
- Sponsor's protocol ID
- UFRGSimplant2014
- Other IDs
- CNPq14_2013
- Acronym
- Perio-implants
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2014
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up
- ClinicalTrials.gov ID
- NCT02241577
- Acronym / sponsor ID
- Perio-implants / UFRGSimplant2014
- Conditions
- Peri-implantitis
- Keywords
- peri-implantitis, dental implants, randomized controlled trial, non-surgical periodontal treatment, will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Experimental | Procedure: Surgical treatmentSurgical access for scaling and disinfection of dental implant |
| Non-surgical treatment | Experimental | Procedure: Non-surgical treatmentNon-surgical subgingival scaling and disinfection of dental implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with at least one dental implant with peri-implantitits
- Individuals with good general health conditions;
- Individuals presenting at least 10 natural teeth;
- Individuals with no signs of active periodontitis
Key exclusion criteria (4 listed)
- Individuals who received periodontal treatment in the last three months
- Pregnant
- Systemic condition that interferes with treatment such as diabetes
- Individuals who are taking or have taken antibiotics or anti-inflammatory medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatmentFlap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia | Procedure or surgery | Surgical treatment |
| Non-surgical treatmentNon-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia | Procedure or surgery | Non-surgical treatment |
Primary outcome
Pocket depth reduction
Time frame: 12 months
6 secondary outcomes
Clinical attachment level changes
Time frame: 12 months
Alveolar bone level changes
Time frame: 12 months
Subgingival microbiota changes
Time frame: 12 months
Gingival crevicular fluid immune-inflammatory biomarkers
Time frame: 12 motnhs
Serum biomarkers of inflammation
Time frame: 12 months
Bleeding on probing
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Site of the School of DentistryLink provided by the sponsor.
- Site of the Post-graduate Program in DentistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cassiano K Rosing, PhD study chair
Federal University of Rio Grande do Sul
Joao Augusto P Oliveira, MS principal investigator
Federal University of Rio Grande do Sul
Tassiane P Wagner, DDS principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment and Non-surgical treatment in people with Peri-implantitis, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket depth reduction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.